Vedolizumab + Cyclophosphamide + Tacrolimus for Graft-versus-Host Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a combination of three medications—vedolizumab (a type of immunotherapy), cyclophosphamide, and tacrolimus—can prevent graft-versus-host disease (GVHD) in patients undergoing a specific type of stem cell transplant. GVHD occurs when transplanted donor cells attack the patient's healthy cells. The trial targets individuals undergoing an allogeneic hematopoietic cell transplant (a procedure involving donor stem cells) after receiving lower doses of chemotherapy. This trial may suit those in remission from certain blood cancers, such as acute leukemia or myelodysplastic syndrome, who qualify for this type of transplant. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those taking other investigational drugs for GVHD prophylaxis and herbal medications. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that vedolizumab is generally safe for patients. In studies, it caused few side effects related to graft-versus-host disease (GVHD) in people receiving stem cell transplants, meaning most patients did not experience major issues.
Trial data suggest that cyclophosphamide is effective and safe for preventing GVHD. It is commonly used in treatment plans for transplant patients, with no unusual safety concerns reported.
Tacrolimus is another medication used to prevent GVHD. Studies have shown it is safe and effective when used as directed. It helps control the immune system to stop it from attacking healthy cells.
In summary, previous studies have shown that the combination of vedolizumab, cyclophosphamide, and tacrolimus is safe, with few serious side effects reported.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for graft-versus-host disease, which primarily involve steroids and other immunosuppressants, vedolizumab targets a specific protein that helps control inflammation in the gut. This targeted approach can potentially reduce the side effects commonly associated with broader immunosuppressive drugs. Researchers are excited about vedolizumab because it could offer a more precise method to manage graft-versus-host disease, potentially improving outcomes and quality of life for patients undergoing allogeneic stem cell transplants.
What evidence suggests that this trial's treatments could be effective for preventing graft-versus-host disease?
Research has shown that vedolizumab, a monoclonal antibody, effectively prevents gut symptoms of acute graft-versus-host disease (aGVHD). It blocks certain immune cells from entering the intestines, reducing inflammation. In this trial, participants will receive a combination of vedolizumab, cyclophosphamide, and tacrolimus. Cyclophosphamide, commonly used in cancer treatments, weakens the immune system to prevent the body from attacking itself. Tacrolimus suppresses the immune system by stopping certain immune cells from becoming active. Together, these treatments have shown promise in lowering the risk of GVHD in patients receiving stem cell transplants.678910
Who Is on the Research Team?
Monzr M. Al Malki
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with certain blood cancers or disorders who are undergoing a stem cell transplant from a donor after receiving lower doses of chemotherapy. It aims to prevent the immune response where transplanted cells attack the patient's body (GVHD).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Participants receive reduced intensity conditioning with fludarabine and melphalan before transplantation
Transplantation and Initial Treatment
Participants undergo allogeneic HCT and receive vedolizumab, cyclophosphamide, and tacrolimus
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Tacrolimus
- Vedolizumab
Trial Overview
The study tests if vedolizumab, combined with cyclophosphamide and short-term tacrolimus after transplant, can prevent GVHD in patients receiving reduced intensity conditioning before allogeneic hematopoietic cell transplantation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive reduced intensity conditioning with fludarabine IV on days -7 to -3 and melphalan IV on day -2. Patients then undergo allogeneic HCT on day 0. Patients also receive vedolizumab IV over 30 minutes on days -1, +13, +41, +69, +97, +125, and +153, cyclophosphamide IV on days +3 and +4, and tacrolimus IV or PO on day +5 to day +95 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT and ECHO or MUGA during screening, blood sample collection on study, and bone marrow biopsy throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Published Research Related to This Trial
Citations
1.
withpower.com
withpower.com/trial/vedolizumab-cyclophosphamide-tacrolimus-for-graft-versus-host-disease-5f0b4Vedolizumab + Cyclophosphamide + Tacrolimus for Graft- ...
Research shows that Vedolizumab is effective for treating gastrointestinal symptoms of graft-versus-host disease, and Tacrolimus has been successful in ...
Vedolizumab for the prevention of intestinal acute GVHD ...
There was a statistically significant difference favoring vedolizumab over placebo for lower-GI aGVHD-free and relapse of the underlying ...
Vedolizumab Plus Post-transplant Cyclophosphamide and ...
This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft ...
Vedolizumab for prevention of graft-versus-host disease after ...
Vedolizumab could help prevent aGVHD by inhibiting the migration of both naive and activated lymphocytes into gut-associated lymphoid tissues ...
5.
ashpublications.org
ashpublications.org/blood/article/142/12/1037/496953/Novel-developments-in-the-prophylaxis-andNovel developments in the prophylaxis and treatment of acute ...
TAC/MTX led to a lower incidence of grade 2 to 4 aGVHD and extensive chronic GVHD (cGVHD), when compared with CSA/MTX in MRD allo-HCT.8 In MUD ...
Post-Transplant Cyclophosphamide for the Prevention of ...
Post-transplant cyclophosphamide (PTCy) emerged as an effective component of graft-vs.-host disease (GVHD) prophylaxis in the nonmyeloablative haploidentical ...
Graft-versus-Host Disease Prophylaxis with ...
Data from two randomized trials have suggested that post-transplantation cyclophosphamide can reduce the risk of GVHD after SCT from a matched ...
Post-Transplant Cyclophosphamide-Based Graft-Versus ...
PTCy-based GVHD prophylaxis after MMUD HSCT with PBSC grafts results in favorable 1 year OS. Using MMUDs expands donor availability to all patients regardless ...
Safety and feasibility of intermediate-dose post-transplant ...
Safety and feasibility of intermediate-dose post-transplant cyclophosphamide for graft-versus-host disease prophylaxis. Case Report; Open ...
Post-transplant cyclophosphamide separates graft-versus ...
Acute GVHD was not associated with relapse (HR 1.37, P = 0.15) but predicted higher NRM (HR 3.34, P < 0.001) and lower OS (HR 1.92, P = 0.001).
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